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Acarbose for Kidney Cancer
Phase 2
Waitlist Available
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically confirmed diagnosis of clear cell or non-clear cell carcinoma of the kidney, except for medullary carcinoma, collecting duct carcinoma, lymphoma and sarcoma. Sarcomatoid features of any degree are allowed
Demonstrates adequate organ function defined as follows: Liver function (bilirubin < 3mg/dL, AST and/or ALT <3 x ULN), Kidney function (CrCL >=15ml/min using cockroft-gault method), ANC >= 500/microliter, Hemoglobin > 8 mg/dL, platelet count > 50,000/microliter
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial is testing a new combination of drugs to treat kidney cancer. They want to see if it's safe and how well it works.
Who is the study for?
This trial is for adults with advanced kidney cancer who haven't had systemic therapy in the last 3 weeks. They must have a certain level of physical ability, agree to use contraception, and have specific organ function levels. Excluded are those with treated diabetes, psychiatric issues affecting study cooperation, recent major surgery or other treatments, severe allergies to acarbose or standard care drugs.Check my eligibility
What is being tested?
The trial tests the safety and effectiveness of acarbose tablets when added to standard immunotherapy in treating advanced renal cell carcinoma. Participants will receive this combination treatment and be monitored for how well they tolerate it and any signs of improvement.See study design
What are the potential side effects?
Potential side effects include digestive issues like gas and bloating since acarbose works in the gut to slow carbohydrate breakdown. There may also be risks associated with combining it with immunotherapy such as fatigue, skin reactions, or flu-like symptoms.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney cancer is not one of the excluded types.
Select...
My liver, kidneys, and blood counts are within the required ranges.
Select...
My kidney cancer is advanced and cannot be surgically removed.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To assess the effect of acarbose on the gut microbiome in patients receiving as standard of care therapy.
To assess the safety profile of acarbose in addition to standard of care (SOC) treatment in RCC
Secondary outcome measures
To assess the efficacy of Acarbose in combination with SOC treatment in RCC
Trial Design
1Treatment groups
Experimental Treatment
Group I: Arm 1Experimental Treatment1 Intervention
Ipilimumab (1 mg/kg) IV q3wks + Nivolumab (3mg/kg) IV q3wks + Acarbose (upto 100 mg PO TID) followed by Nivolumab 480 mg IV q4 wks + Acarbose (upto 100 mg PO TID)
OR
Pembrolizumab 200 mg IV q3 wks or 400 mg IV q6 wks + Lenvatinib (up to 20 mg PO Daily) + Acarbose (upto 100 mg PO TID) [ Frontline/Refractory pts]
OR
Lenvatinib (upto 18 mg PO daily) + Everolimus (upto 5 mg PO Daily) + Acarbose (upto 100 mg PO TID) [ Refractory pts]
OR
Cabozantinib (upto 60 mg PO Daily) + Acarbose (upto 100 mg PO TID) [Refractory pts]
Find a Location
Who is running the clinical trial?
University of Alabama at BirminghamLead Sponsor
1,581 Previous Clinical Trials
2,278,005 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not received a live virus vaccine in the last 30 days.I am currently being treated for an infection.My diabetes is managed with medication and my HbA1c is below 8.I started bone-strengthening treatment at least 2 weeks ago.I have had low blood sugar episodes in the past year.I have untreated brain metastases or carcinomatous meningitis.I haven't fully recovered from side effects of my last treatment or had major surgery or radiation in the last 4 weeks.I agree to use birth control from the start of the study drug until 120 days after the last dose.I am not using, nor do I plan to use, certain medications like carbamazepine or St. John's wort.You have a condition that can be measured by the doctor using a specific assessment tool.My liver, kidneys, and blood counts are within the required ranges.I agree to use birth control during and up to 120 days after the study.I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.My blood pressure is high despite taking 3 or more medications for it.My kidney cancer is not one of the excluded types.I haven't had any treatments for advanced kidney cancer in the last 3 weeks.I am mostly independent and can care for myself.You have had an organ transplant in the past.I have not had active GI bleeding or unresolved issues in the last 3 months.You have a serious autoimmune disease that has needed strong medication in the last 2 years or you have a history of severe autoimmune disease.My brain metastasis was treated over 3 weeks ago, and I've had no new symptoms since.I have another cancer that has worsened or needed treatment in the past 3 years.I am currently using or might need strong CYP3A4/5 inhibitors.Your heart takes too long to recover between beats, which can be dangerous.You have had a strong allergic reaction to acarbose or the standard treatment chosen by the doctor.I have had serious heart or stroke issues in the last 6 months.I have a GI condition that affects how my body absorbs pills.I have coughed up blood in the last 6 weeks.My kidney cancer is advanced and cannot be surgically removed.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 1
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this trial currently open for enrollment?
"According to the clinicaltrials.gov database, this medical research project is not currently recruiting participants. The entry was initially submitted on February 1st 2023 and has since undergone its last edit on November 1st 2022. Yet, there are a total of 423 trials seeking new candidates across the United States at present."
Answered by AI
What possible adverse effects may arise from taking Acarbose Tablets?
"While Phase 2 trials do not provide evidence of efficacy, there is available data suggesting Acarbose Tablets are safe and thus were given a score of two."
Answered by AI
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